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FDA 510(k)

Infusion Sets for Single Use with Needles

K-Number: K221069 · 2022-11-21

ApplicantSichuan Prius Biotechnology Co., Ltd.
Decision Date2022-11-21
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infusion Sets for Single Use with Needles is the device name listed in this FDA 510(k) record. The listed applicant is Sichuan Prius Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K221069. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Infusion Sets for Single Use with Needles?

Infusion Sets for Single Use with Needles is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Sichuan Prius Biotechnology Co., Ltd.. The 510(k) number is K221069.

When did Infusion Sets for Single Use with Needles receive FDA 510(k) clearance?

Infusion Sets for Single Use with Needles received FDA 510(k) clearance on 2022-11-21, under 510(k) number K221069.

Who is the listed applicant for Infusion Sets for Single Use with Needles?

The FDA 510(k) record lists Sichuan Prius Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infusion Sets for Single Use with Needles?

The FDA product code for Infusion Sets for Single Use with Needles is FPA.

Other records listing Sichuan Prius Biotechnology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221078Intravenous Needles for Single Use,Safety Intravenous Needles for Single UseK221075Infusion Sets for Single UseK221080Sterile Safety Hypodermic Needles for Single UseK221079Sterile Hypodermic Syringes for Single UseK221073Sterile Hypodermic Syringes for Single Use with Safety NeedlesK221068Sterile Hypodermic Syringes for Single Use with Needles

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Related Devices (Code: FPA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)K251814EZ™ IV Administration SetEpic Medical Pte. , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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